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Trial Title:
Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer
NCT ID:
NCT05677802
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Hormone Receptor-Negative Breast Carcinoma
Triple-Negative Breast Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Health Services Research (stress management therapy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Medical Chart Review
Description:
Undergo medical cart review
Arm group label:
Health Services Research (stress management therapy)
Other name:
Chart Review
Intervention type:
Procedure
Intervention name:
Stress Management Therapy
Description:
Receive biobehavioral stress reduction intervention
Arm group label:
Health Services Research (stress management therapy)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Health Services Research (stress management therapy)
Summary:
This clinical trial aims to see if patients with triple negative breast cancer can
complete a biobehavioral stress reduction program that also addresses health related
social needs (e.g., utilities, transportation, etc.). The stress reduction program is
over ten weeks and includes stress reduction (e.g., progressive muscle relaxation),
coping, problem solving, communication, and social support. Health related social needs
will be evaluated at the beginning of the study, and referrals will be made to social
work to help address those needs. The study will examine stress as reported by the
patients and also use biological markers.
Detailed description:
PRIMARY OBJECTIVES:
I Acceptability of the biobehavioral intervention will be determined using the Client
Satisfaction Questionnaire (CSQ). CSQ is an 8-item self-report measure with item
assessing different aspects of treatment satisfaction (e.g., quality of service, the
degree to which needs were met, overall satisfaction).
III Tolerability of the biobehavioral intervention will be assessed by analyzing pre to
post treatment change on the Profile of Mood States.
III Feasibility of the biobehavioral intervention will be assessed using three metrics:
1) accrual number as a percentage of available patients approached; 2) number/percent of
patients completing each BBI session; and, 3) number/percent of patients retained and
completing 10 BBI sessions.
SECONDARY OBJECTIVE:
I. To examine the feasibility of collecting biomarkers--white blood cell count,
C-reactive protein, Interleukin-6, TNF-alpha (α), systolic blood pressure, diastolic
blood pressure, heart rate, total cholesterol, high-density lipoprotein; albumin,
hemoglobin A1C, body mass index (BMI).
EXPLORATORY OBJECTIVE:
I. To test for pre/post effects of the biobehavioral stress reduction intervention on
measures of stress (Impact of Events Scale), mood and psychological symptoms, and
allostatic load.
OUTLINE:
Patients receive biobehavioral stress reduction intervention while on study. Patients
undergo blood specimen collection at baseline and follow up, and have their medical
records reviewed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age >=18 years
- Untreated newly diagnosed triple negative breast cancer
- Stages I-III
Exclusion Criteria:
- Prisoners
- Male
- Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other
Pacific Islander
- Individuals not able to speak and understand English
- Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer
- Stage IV breast cancer
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samilia Obeng-Gyasi, MD, MPH
Phone:
614-293-6408
Email:
samilia.obeng-gyasi@osumc.edu
Investigator:
Last name:
Samilia Obeng-Gyasi, MD, MPH
Email:
Principal Investigator
Start date:
December 14, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05677802
http://cancer.osu.edu
